Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis: A phase III, randomized, placebo-controlled trial in Taiwanese and Korean patients (PEARL)

IL12/IL23 Inhibition in the Treatment of Psoriatic Arthritis

“…The PEARL trail was a randomized DBPC trial of 121 Taiwanese and Korean patients with moderate-to-severe psoriasis randomized with a treatment with 45 mg of UST vs. placebo. The results showed that the efficacy (and safety) rates in Asian patients were consistent with previous studies [39]. In 2009, the Food and Drug Administration approved its use for adult patients with moderate-to-severe plaque psoriasis in the US, and approval for this indication in Canada and Europe followed shortly thereafter.…”

Impact of biologic therapies on risk of major adverse cardiovascular events in patients with psoriasis: systematic review and meta-analysis of randomized controlled trials

“…In all, 38 RCTs (identified in 38 reports)20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57 met the eligibility criteria and were included, as shown in Figure 1. These trials involved a total of 18 024 patients with plaque psoriasis.…”

“…Eighteen RCTs compared TNFi (four adalimumab,20, 21, 22, 23, 24 nine etanercept,26, 27, 28, 29, 30, 31, 32, 34, 35 five infliximab36, 37, 38, 39, 40) with placebo, with three studies reporting MACEs; four RCTs compared ustekinumab (anti‐IL‐12/23) with placebo46, 47, 48 with no MACEs reported. One RCT compared ixekizumab with placebo without MACEs reported 56, 57.…”

“…Patients in 27 RCTs20, 21, 22, 25, 27, 28, 29, 30, 31, 34, 35, 36, 37, 38, 39, 40, 43, 45, 46, 47, 48, 50, 52, 53, 57 did not experience MACEs while exposed to any interventions but 10 MACEs were observed during the randomized controlled phase of nine studies 23, 26, 32, 33, 42, 44, 49, 51. Overall, the pooled analysis of these nine trials found that there was no statistically significant difference in the risk of MACEs when comparing biologic therapies with placebo (pooled OR 1·45, 95% CI 0·34–6·24, P  = 0·62), as shown in Figure 2a.…”

Squamous Cell Carcinoma of the Tongue in a Patient on Ustekinumab as the Treatment of Psoriasis

“…To understand the potential risks of malignancies from ustekinumab therapy, five randomized placebo-controlled trials of ustekinumab for the treatment of moderate-to-severe plaque psoriasis and three meta-analyses of randomized controlled trials and open-label extension studies were identified through literature review [10][11][12][13][14][15][16][17][18]. In general, malignancy excluding NMSC was not significantly increased in patients receiving long-term ustekinumab therapy when compared with The National Cancer Institute's Surveillance Epidemiology and End Results (NCI SEER) database [15,17].…”